Risedronate to Prevent Bone Loss After Sleeve Gastrectomy: Study Design and Feasibility Report of a Pilot Randomized Controlled Trial.

Mounting evidence implicates bariatric surgery as a cause of increased skeletal fragility and fracture risk. Bisphosphonate therapy reduces osteoporotic fracture risk and may be effective in minimizing bone loss associated with bariatric surgery. The main objective of this pilot randomized controlled trial (RCT; Clinical Trial No. NCT03411902) was to determine the feasibility of recruiting, treating, and following 24 older patients who had undergone sleeve gastrectomy in a 6 month RCT examining the efficacy of 150-mg once-monthly risedronate (versus placebo) in the prevention of surgical weight-loss-associated bone loss. Feasibility was defined as: (i) >30% recruitment yield, (ii) >80% retention, (iii) >80% pills taken, (iv) <20% adverse events (AEs), and (v) >80% participant satisfaction. Study recruitment occurred over 17 months. Seventy participants were referred, with 24 randomized (34% yield) to risedronate (n = 11) or placebo (n = 13). Average age was 56 ± 7 years, 83% were female (63% postmenopausal), and 21% were black. The risedronate group had a higher baseline BMI than the placebo group (48.1 ± 7.2 versus 41.9 ± 3.8 kg/m2). The 10-year fracture risk was low (6.0% major osteoporotic fracture, 0.4% hip fracture); however, three individuals (12.5%, all risedronate group) were osteopenic at baseline. Twenty-one participants returned for 6-month follow-up testing (88% retention) with all (n = 3) loss to follow-up occurring in the risedronate group. Average number of pills taken among completers was 5.9 ± 0.4 and 6.0 ± 0.0 in the risedronate and placebo groups, respectively (p = 0.21), with active participants taking >80% of allotted pills. Five AEs (3.7% AE rate) were reported; one definitely related, four not related, and none serious. All participants reported high satisfaction with participation in the study. Use of bisphosphonates as a novel therapeutic to preserve bone density in patients who had undergone a sleeve gastrectomy appears feasible and well-tolerated. Knowledge gained from this pilot RCT will be used to inform the design of an appropriately powered trial. CLINICAL TRIAL REGISTRATION: http://clinicaltrials.gov/show/NCT03411902. Weight Loss With Risedronate for Bone Health. © 2020 The Authors. JBMR Plus published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research.

Genome Sequences of Mycobacteriophages AlanGrant, Baee, Corofin, OrangeOswald, and Vincenzo, New Members of Cluster B.

AlanGrant, Baee, Corofin, OrangeOswald, and Vincenzo are newly isolated phages of Mycobacterium smegmatis mc(2)155 discovered in Pittsburgh, Pennsylvania, USA. All five phages share nucleotide similarity with cluster B mycobacteriophages but span considerable diversity with Corofin and OrangeOswald in subcluster B3, AlanGrant and Vincenzo in subcluster B4, and Baee in subcluster B5.

Pilot study of electrical stimulation on median nerve in comatose severe brain injured patients: 3-month outcome.

PRIMARY OBJECTIVE: To determine if electrical stimulation (ES) benefits (waking time, 3-month outcomes) treated coma patients. RESEARCH DESIGN: Double blind randomized-controlled study. METHODS AND PROCEDURES: Ten coma patients; six treatment and four controls, using the 'Respond Select' by EMPI. EXPERIMENTAL INTERVENTIONS: Treatment group received radial nerve ES applied in 300 ms intermittent pulses at 40 Hz, 15-20m A 8 hours a day up to 14 days of coma; control group received sham stimulation. MAIN OUTCOMES AND RESULTS: ES group emerged from coma mean 2 days earlier than controls, although this result was not statistically significant. At 3 months post-injury, there was no group difference in Glasgow Outcome Scale, although the ES group had improved function over controls as measured by the FIM/FAM (mean of 114 and 64.5, respectively, n.s.). CONCLUSIONS: These data show an interesting trend, although statistical power was limited in this small pilot study, suggesting the need for a larger trial.

Properties of tomato powders as additives for food fortification and stabilization.

The antioxidant activities of two freeze-dried tomato powders as additives for food fortification and stabilization were studied. The two tomato powders were obtained from the whole fruit and from the pulp after "serum" separation, respectively. The antioxidant activity was studied by measuring (a) the inhibition of the singlet oxygen-catalyzed oxidation of alpha-linolenic acid, in the presence or absence of copper ions, as a model of the oxidative processes occurring in foods, and (b) the inhibition of xanthine oxidase (XOD)- and myeloperoxidase (MPO)-catalyzed reactions and copper-induced lipid peroxidation. The partial separation of "serum" decreased the freeze-drying time by 50%. The partially fractionated tomato powder had a 60% lower phenolic content and an 11-fold higher lycopene content than the whole tomato powder, on a dry weight basis. Ascorbic acid was almost completely removed by fractionation. Both the powder obtained from the whole tomato and that obtained from the partially fractionated tomato had antioxidant activity in all the model systems used. Based on these results, we conclude that tomato powders have multifunctional properties, which could address the prevention of oxidative degradations both in foods and in vivo. Therefore, tomato can be regarded as source of food additives for fortification and stabilization, even if it is submitted to technological processes that can cause the loss of the more labile hydrophilic antioxidants.

Antioxidant activity of tomato products as studied by model reactions using xanthine oxidase, myeloperoxidase, and copper-induced lipid peroxidation.

The antioxidant content and activity of commercial tomato products differing in variety and processing were studied. Two procedures for extracting hydrophilic and lipophilic antioxidants, namely, two-step 0.1 M phosphate buffer (pH 3.0 and 7.4) extraction and tetrahydrofuran extraction followed by petroleum ether fractionation, were developed. Carotenoids (lycopene, beta-carotene, and lutein) and ascorbic acid were analyzed by HPLC with spectrophotometric and electrochemical detectors, respectively. Total phenolics were determined by using the Folin-Ciocalteu reagent. The antioxidant activity was studied by the following three model systems: (a) the xanthine oxidase (XOD)/xanthine system, which generates superoxide radical and hydrogen peroxide; (b) the myeloperoxidase (MPO)/NaCl/H(2)O(2) system, which produces hypochloric acid; and (c) the linoleic acid/CuSO(4) system, which promotes lipid peroxidation. Results showed that the hydrophilic and lipophilic fractions of all tomato products were able to affect model reactions, whatever reactive oxygen species and catalysts were used to drive oxidation. In the XOD/xanthine system both the hydrophilic and lipophilic fractions displayed an inhibitory activity. The hydrophilic fractions were more effective (I(50) ranging from 680 to 3200 microg, dry weight) than the lipophilic fractions (I(50) ranging from 4000 to 7750 microg, dry weight). In the MPO/NaCl/H(2)O(2) system the hydrophilic fractions inhibited oxidation (I(50) ranging from 2300 to 2900 microg, dry weight), whereas the lipophilic fractions had a lower inhibitory effect at the same concentration. Conversely, in the copper-catalyzed lipid peroxidation only the lipophilic fractions were effective (I(50) ranging from 1030 to 2100 microg, dry weight), whereas the hydrophilic fractions had a pro-oxidant effect in the same concentration range. The extent of inhibition varied according to the tomato sample in the superoxide and hydrogen peroxide generating system and in lipid peroxidation, but was substantially the same in the HClO generating system. Fresh tomato varieties differed considerably in the antioxidant activities of their hydrophilic and lipophilic fractions. Processed tomatoes showed a significantly lower antioxidant activity than fresh tomatoes in their hydrophilic fractions but had a high antioxidant activity in their lipophilic fractions. Because the oxidative reactions produced by the above-mentioned model systems are also involved in the pathogenesis of several chronic diseases, the antioxidant activity of tomato fractions might be related to their in vivo activity. Hence, these measurements may be used for optimizing tomato technologies.

Evaluation of radical scavenging activity of fresh and air-dried tomatoes by three model reactions.

The radical scavenging activity and the antioxidant content of fresh and air-dried tomatoes were investigated. Tomato halves were dried in a pilot-scale dryer under the following conditions: air temperature, 80 degrees C; air flow rate, 1.5 m/s; drying time, 400 min; final moisture, 25%. Carotenoid (lycopene, beta-carotene, lutein) and ascorbic acid were analyzed by HPLC with a spectrophotometric and an electrochemical detector, respectively. Total phenolics were determined by using the Folin-Ciocalteu reagent. The radical scavenging activity was studied in three model systems: (a) the xanthine oxidase and xanthine system, which generates superoxide radical and hydrogen peroxide; (b) the 3-morpholinosydnonimine system, which releases spontaneously superoxide radical and nitrogen monoxide, forming peroxynitrite; (c) the linoleic acid and CuSO(4) system, which promotes lipid peroxidation. These model systems allow the simulation of key reactions involved in the pathogenesis of certain chronic diseases and may be related to the in vivo activity of tomato antioxidants. Hence, these measurements can be used for optimizing tomato processing and storage. The drying process resulted in a decrease of ascorbic acid content, whereas phenol reagent reducing compounds increased. Carotenoid levels were substantially unchanged upon drying. Fresh and air-dried tomato extracts could act as radical scavengers both in the reactive oxygen species-mediated reactions and in lipid peroxidation. Drying affected the antioxidant effectiveness as measured in the xanthine/xanthine oxidase system, which was found to be the most sensitive method for the measurement of tomato antioxidant activity (lower I(50)) but retained the antioxidant effectiveness in the other two systems.

[Malaria: recent immunological acquisitions and therapeutic prospects]. / La malaria: recenti acquisizioni immunologiche e prospettive terapeutiche.

Malaria remains one of the major health problems in many tropical countries. The asymptomatic carrier status is common and about 100% of the children in highly endemic areas have Plasmodium falciparum parasitaemia at any given time. Consequently a case definition based on the mere presence of parasites in the blood is non-informative in terms of measuring morbidity. Acquired clinical and parasitological immunity develop progressively over several years after repeated exposure to infection. Protection is acquired first again death or severe clinical disease, but protection against infection is never complete, moreover it is still not known why some infections are mild an some fatal. Although virulence markers on the parasite have not been identified with certainty, there are some indications that parasites differ in virulence. The genetic composition of human many also play a role in the defence against the parasite, so the immune mechanisms responsible for the acquired immunity remain uncertain. In fact, an infection by Plasmodium falciparum induces a variety of immune responses, including humoral and cellular, which can be specific or non-specific responses, some of which are protective, but against which the parasite has evolved effective escape measures. Vaccines has proven a most effective measure to control infectious diseases, but no consistently effective vaccine has yet developed against a human parasitic disease. A malaria vaccine aimed at disrupting the parasites life cycle at one or more of the three stages (sporozoite or pre-erythrocytic stage, asexual blood or erythrocytic stage, and sexual or sporogonic stage) might be a long-term solution.

[CD5 positive b-lymphocytes in autoimmunity: possible role in Graves' disease]. / Linfociti BCD5+ ed autoimmunità: possibile ruolo nella malattia di Graves.

CD5+B cells, recently defined B-1a cells, are the main clonotype in the early B cell repertoire and persist throughout adult life. This subset is committed to the production of antibodies, defined "natural antibodies", that bind a lot of exogenous antigens, isologous and heterologous serum proteins, tissues and/or self antigens, such as hormones, nucleic acids and phospholipids. These antibodies, mostly IgM, but also IgG and IgA, are polyreactive: their role is likely that of first line of defence against invading microorganisms. Natural antibodies produced by CD5+ B cells may be involved in maintenance functions such as removal of dead cells. Because of their ability to bind self antigens, they may be important in the establishment of autoimmune phenomena. An increase of CD5+ B cells has been demonstrated in some autoimmune disorders. The authors examine the functional characteristics and the expansion of this subset in different diseases. In particular they report the increase in active Graves' disease and discuss the role of CD5+ B lymphocytes in the immune imbalance present in this thyropathy.

Acute ethanol hepatotoxicity is modulated by bile salt hydrophilic-hydrophobic properties.

The influence of the hydrophobic-hydrophilic properties of bile salts (BS) on acute ethanol hepatotoxicity was investigated. Bile flow, biliary BS secretion and enzyme (LDH,AST) release in the perfusate were measured before and after exposure to low (0.1%) or high (1%) doses of ethanol in in vitro isolated livers perfused with 1 microM/min taurocholate (TCA), tauroursodeoxycholate (TUDCA) or taurodeoxycholate (TDCA). Ethanol promotes a rapid decrease of basal bile flow and BS secretion in TCA-perfused livers [-28% of basal values with 0.1% (N = 6), and -35% with 1% ethanol (N = 6)]. Bile flow and BS secretion were minimally decreased by ethanol in livers perfused with a hydrophilic BS (TUDCA) [-8% decrease of basal values with 0.1% ethanol (N = 6), and -10% with 1% ethanol (N = 9); p < 0.02 vs TCA-perfused livers]. In contrast, when livers were perfused with a hydrophobic BS (TDCA), ethanol showed a higher cholestatic effect than either TCA- or TUDCA-perfused livers. Enzyme release in the perfusate was not modified by 0.1% ethanol, while 1% ethanol promoted a 4-5 fold increase in LDH and AST release in the perfusate of TCA-perfused livers with respect to a mere 2-fold increase in TUDCA-perfused livers and a 6-7 fold increase in TDCA perfused livers (p < 0.03). In conclusion, we showed that TUDCA almost completely counteracts the cholestatic and cytolitic effects promoted by ethanol in the isolated perfused rat liver.

Conservative treatment for multilocular empyema. Case report.

The case of a 35-year-old patient is reported. After a two-week interval following an ORL puncture in the frontal sinuses, the patient showed a suppuration on the right hemisphere and was admitted in the territorial neurosurgical clinic. Due to a progressive neurological impairment (loss of consciousness and left hemiplegia) the patient was transferred to the Neurological Clinic of "G. Marinescu" Hospital, in Bucharest. CT-scanning carried out in 1989, showed multiple empyemas (intrahemispheric, basal, etc.) excluding any surgical treatment. A conservative treatment was administered during a long period including antibiotics, notably cephalosporines (the third generation). Repetition of CT-scanning evidenced a progressive diminution of a total disappearance of septic intracranial collection, hence, an obvious improvement of the patient. After a year of treatment, the patient was considered to be recovered even if he still accused rare epileptic seizures, partially controlled by drug therapy.

[Development of a "vortex bed" drying apparatus]. / Sviluppo di un impianto di essiccamento in "letto a vortice"

Fundamental parameters in dimensioning a "vortex bed" drying apparatus are the pressure drop across the bed and the higher and lower limit of fluidization velocity. The analysis of the Navier-Stokes equations brings to the following functional relations between dimensionless groups: (see journal). These relations define the fluidization conditions in a "vortex bed" apparatus. Experimental tests carried out on a laboratory scale apparatus will provide us with the unknown constants for industrial scale extrapolation.

[Search of optimum survival conditions for lactic acid bacteria in powders obtained by spray drying of yoghurt]. / Ricerca delle condizioni ottimali di sopravvivenza dei fermenti lattici in polveri ottenute per essiccamento spray dello yogurt

The paper reports the results of two spray-drying tests carried out on yogurt as such or previously neutralized. The operating conditions of the drying operation were such that the temperature of the product didn't exceed 80 degrees C, and the residual moisture of the powder was about 10%, slightly higher than the B.E.T. monolayer value. The decrease of total counts was three and two decimal reductions respectively for the natural and neutralized product. This latter gave also much higher viability index as determined in a "fermenting activity" test. Also, the analyses, related to the quality of the protein fraction, strongly support the opportunity of neutralization before drying. In storage tests carried out during 8 months the survival data were higher at 5% relative humidity (corresponding to 7-8% humidity) and at 5 degrees C temperature. In all cases the better results were obtained from the powders of neutralized yogurt, even in comparison with a freeze-dried sample obtained from the natural product. The typical shape of the sorption isotherms of these products suggests that the optimum process as regard to microorganisms' survival consists in drying the neutralized product up to residual humidities of 8-10%, followed by storage, in humidity-proof containers, at temperatures of about 5 degrees C.

[Progresses in the concentration of foodstuffs (author's transl)]. / Progressi nelle tecnologie di concentrazione dei prodotti alimentari liquidi

The article reports a description and a comparison of three concentration techniques: evaporation, freeze-concentration and reverse osmosis. The discussion is particularly concerned with the problems of aroma losses and retention and, for evaporation, the problems of heat damage and fouling. The increase in viscosity with concentration and the markedly non-newtonian behaviour of most food products are such that only evaporation allows to achieve high concentrations. The major progresses in evaporation plants and techniques are discussed in terms of heat transfer efficiency and residence time. Freeze-concentration and reverse osmosis are suitable for pre-concentration up to 30-35 10Brix of heat sensitive and aromarich products